LAVA Therapeutics N.V. (NASDAQ: LVTX), a clinical-stage immuno-oncology company focused on bispecific gamma-delta T cell engagers, announced its first quarter 2025 financial results and provided a business update on May 14, 2025. The company is implementing significant operational restructuring while continuing to advance its clinical programs.
Strategic Restructuring and Netherlands Operations Closure
LAVA has initiated a comprehensive restructuring plan to optimize resources and extend its capital runway while evaluating strategic alternatives. The plan includes a 30% reduction in global workforce and the complete closure of its Netherlands operations.
"LAVA's top priority remains delivering shareholder value through an evaluation of strategic alternatives," said Steve Hurly, Chief Executive Officer of LAVA. "To support this process, we have taken actions to streamline our operations by implementing a significant reduction in workforce as part of a restructuring plan, which includes the closure of our Netherlands operations."
The company has secured a $5.2 million repayment waiver from the Netherlands Enterprise Agency (Rijksdienst voor Ondernemend Nederland, RVO), providing additional financial flexibility. LAVA expects to incur approximately $2.0 million in expenses related to the Netherlands closure during 2025, with the elimination of all remaining Netherlands positions by July 31, 2025.
Clinical Pipeline Progress
Despite the restructuring, LAVA continues to advance its proprietary Gammabody® platform technology across multiple clinical programs:
LAVA-1266 (Internal Program):
- Phase 1 trial (ACTRN12624001214527) targeting CD123+ tumor cells for hematological malignancies
- Currently enrolling patients at the 300 μg dose level in Australia and Spain
- Designed to treat up to 50 adults with CD123+ relapsed/refractory acute myeloid leukemia (AML) or intermediate to extremely high-risk myelodysplastic syndrome (MDS)
Johnson & Johnson Partnered Program (JNJ-89853413):
- Phase 1 trial (NCT06618001) targeting CD33 and gamma delta T cells
- Currently enrolling patients in Canada and Spain
- Evaluating approximately 100 adults with relapsed/refractory AML or higher-risk MDS
- LAVA received a $5 million development milestone from J&J in Q4 2024 related to the IND filing
Pfizer Partnered Program (PF08046052):
- Phase 1 trial (NCT05983133) targeting epidermal growth factor receptor (EGFR)
- Currently enrolling patients in the U.S. and UK
- Designed to evaluate approximately 275 subjects with advanced solid tumors
- LAVA received a $7 million clinical development milestone from Pfizer in Q1 2024
Financial Results for Q1 2025
LAVA reported a solid financial position despite ongoing restructuring efforts:
- Cash, cash equivalents, and short-term investments: $66.6 million as of March 31, 2025 (compared to $76.6 million as of December 31, 2024)
- Expected cash runway: into 2027
- Revenue: $0 for Q1 2025 (compared to $7.0 million for Q1 2024, which reflected a milestone payment from Pfizer)
- Research and development expenses: $4.2 million for Q1 2025 (compared to $5.6 million for Q1 2024)
- General and administrative expenses: $3.4 million for Q1 2025 (unchanged from Q1 2024)
- Other income: $4.3 million for Q1 2025 (compared to $1.5 million for Q1 2024), primarily due to the $5.2 million gain from the RVO repayment waiver
- Net loss: $3.5 million, or $0.13 per share, for Q1 2025 (compared to $0.6 million, or $0.02 per share, for Q1 2024)
Gammabody® Platform Technology
LAVA's proprietary Gammabody® platform utilizes bispecific antibodies engineered to selectively kill cancer cells by triggering Vγ9Vδ2 (Vgamma9 Vdelta2) T cell anti-tumor effector functions upon cross-linking to tumor-associated antigens. This approach is being applied to both hematological malignancies and solid tumors.
The company's pipeline includes one internal and two partnered clinical-stage bispecific gamma-delta T cell engagers, along with several preclinical programs. LAVA's technology aims to harness the unique properties of gamma-delta T cells, which combine characteristics of both innate and adaptive immunity, potentially offering advantages over conventional immunotherapies.
Looking Forward
As LAVA continues its strategic review process, the company remains focused on advancing LAVA-1266 while supporting its partnered programs with Johnson & Johnson and Pfizer. The restructuring initiatives are expected to extend the company's cash runway while management evaluates potential strategic alternatives to maximize shareholder value.
The company plans to provide further updates on LAVA-1266, partnered programs, and the evaluation of strategic alternatives as developments warrant.
